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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002007
Receipt No. R000002444
Scientific Title A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase
Date of disclosure of the study information 2009/06/01
Last modified on 2014/06/04

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Basic information
Public title A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase
Acronym Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)
Scientific Title A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase
Scientific Title:Acronym Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)
Region
Japan

Condition
Condition Chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Nilotinib in patients with imatinib-resistant or intolerant Ph+CML-CP.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To assess the rate of major molecular response at 12 months of nilotinib therapy.
Key secondary outcomes 1) To evaluate the response rates at 12 and 24 months of nilotinib therapy.
2) To evaluate the safety of nilotinib
3) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 3 years.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nilotinib will be administered twice daily at a dose of 400 mg (800 mg/day) for 2 year.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP.
2) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance.
3) ECOG performance status of 0-2.
4) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib.
5) Adequate organ function.
6) Patients who are able to attend the study institution in accordance with the designated follow-up visit schedule.
7) Written informed consent prior to any study procedures being performed.
Key exclusion criteria 1) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry.
2) Patients whose clone exhibit the T315I BCR-ABL mutation.
3) Patients who have any cardiac disturbances.
4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.
5) Severe medical conditions.
6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Wakita
Organization Japanese Red Cross Society Narita Hospital
Division name Hematology & Oncology
Zip code
Address 90-1 Iidacho Narita, Chiba, 286-8523 Japan
TEL 0476-22-2311
Email wakita@naritasekijyuji.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniaki Itoh
Organization National Cancer Center Hospital East
Division name Division of Oncology/Hematology
Zip code
Address 6-5-1 Kashiwanoha Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Homepage URL
Email kaito@east.ncc.go.jp

Sponsor
Institute Shimousa Hematology Study Group
Institute
Department

Funding Source
Organization Ibaraki Hematology, Oncology & Palliation Expert Meeting(IB-HOPE)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 26 Day
Last modified on
2014 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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